Lower risk Medical device recall · FDA · Published February 10, 2025

Immuno-Mycologics Candida ID Antigen Recall: False Negative Risk

Immuno-Mycolog: Candida ID Antigen products may give false negative results. Recalled due to reduced sensitivity. Contact for replacement.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1389-2025Medical device Immuno-Mycologics ›

Lower-risk recall

Candida Immunodiffusion Antigen may have reduced sensitivity which could result in false negative results.

Take action

Contact the company

Recalling firmImmuno-Mycologics, Inc2701 Corporate Centre Dr · Norman, OK 73069-2901

✎ GovInfoNow plain-language explainer

Immuno-Mycologics is recalling Candida ID Antigen test kits because they might give false negative results. This means the test could miss infections that are actually present, which is risky for people needing accurate diagnosis. Read more at govinfonow.com/recall/52927-immuno-mycologics-candida-id-antigen-recall-false-negative-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/52927-immuno-mycologics-candida-id-antigen-recall-false-negative-risk · Updated August 18, 2026 · FDA enforcement record: FDA #Z-1389-2025

Cite this page

“Immuno-Mycologics Candida ID Antigen Recall: False Negative Risk.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/52927-immuno-mycologics-candida-id-antigen-recall-false-negative-risk. Based on FDA recall #Z-1389-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1389-2025%22&limit=1).

The FDA announced on Feb. 10, 2025, that Immuno-Mycologics, Inc. is recalling Candida ID Antigen and related fungal antigen positive controls due to potential reduced sensitivity causing false negative results. The company initiated this voluntary Class II recall.

How to tell if you have it

Brand: Immuno-Mycologics
Product: Candida ID Antigen, REAG, AG, REF C50110, Vol 1 mL REF ID1001, Immy Fungal Antigens, Positive Controls
Lot #: F4171005
UDI: 00816387020223

The hazard

The Candida Immunodiffusion Antigen may have reduced sensitivity which could result in false negative results, according to the FDA.

Context

GovInfoNow's records show Immuno-Mycologics, Inc. has 4 other recalls on record since 2018-03-30. Other recent recalls of similar products include Meridian Bioscience Revogene C. difficile Test Recall (2025-12-05) and Biomerieux VITEK 2 AST-N461 Test Kit Recall (2026-07-24).

How to tell if you have this one

Check for the product names: Candida ID Antigen, REAG, AG, REF C50110, Vol 1 mL, REF ID1001, Immy Fungal Antigens, Positive Controls, and Immunodiffusion plates. These are for medical use only and sold with specific lot numbers.

Brand
Immuno-Mycologics
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Product Details
Look for the product names and lot numbers listed in the recall notice to confirm if your kit is affected.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 2 states.

FDA distribution: “Worldwide - US Nationwide distribution in the states of CA and OK and the countries of Peru France, Austria, Venezuela.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: California, Oklahoma.

Recall timeline

FDA published this recall 44 days after the firm started it.

Feb 10, 2025Firm started the recall
Mar 18, 2025FDA classified it Class II
Mar 26, 2025Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

Is this product safe to use?

The recall indicates a potential risk of false negative results, but the product is not unsafe in normal use.

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Link to this recall

<a href="https://govinfonow.com/recall/52927-immuno-mycologics-candida-id-antigen-recall-false-negative-risk">Immuno-Mycologics Candida ID Antigen Recall: False Negative Risk (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-1389-2025 (February 10, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1389-2025 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.